The present invention relates to pharmaceutical preparations useful in the treatment of tumors and lesions of the skin and the mucous membranes, and methods and kits using same.
Human skin and mucousal membranes support a wide range of growth abnormalities which exhibit a wide range of sizes, shapes and colors. Although not always dangerous to the individual, such growth abnormalities are frequently cosmetically unappealing and as such are oftentimes a cause of great discomfort. In addition, such growth abnormalities are also prone to injury and infection and can be a source of physical pain or discomfort.
Genital warts (condylomata acuminata) are a sexually transmitted disease caused by the human papilloma virus (HPV). Since the 1970's it has been increasingly clear that infections by the same virus are closely implicated in the aetiology of anogenital squamous cell carcinomas and in their precursors known as dysplasia, intraepithelial neoplasia (CIN) or squamous intraepithelial lesions (SIL).
Cutaneous melanoma, another skin lesion, which is also known as “the great masquerader”, is often recognized by its dark color, although some tumors, defined as amelanotic melanomas, have little or no pigmentation and as such are hard to detect and diagnose.
Due to limited diagnostic capabilities, physicians often rely upon biopsy specimen analysis for accurate diagnosis of a suspected malignant melanoma.
However, at present, most lesions which are not suspected as being malignant are not biopsied but are rather treated via methods such as cryosurgery, laser therapy or electrocauterization which destroy the treated skin region making histopathological diagnosis impossible.
In addition, such treatment methods oftentimes lead to complications including pain, bleeding and discharge as well as infections, blistering and hematomas. Such complications often necessitate the application of localized antibiotics as well as bandaging and as such are liable to cause further discomfort to the individual treated.
Furthermore, with such treatments, the healing process is liable to be slow and prolonged inevitably concluding with the formation of an ugly scar which can be a source of discomfort, particularly when appearing on exposed areas of the body such as the neck and face.
Finally, such methods are also limited by the use of expensive equipment not available in most clinics; furthermore, cryosurgery requires a current and permanent supply of liquid nitrogen, and is thus limited by the logistic hardships imposed by such requirements.
An alternative method of treating lesions such as, warts and condylomata acuminata, involves topical application of Solcoderm™ (manufactured and distributed by Solco Basel AG, Switzerland), a medication which includes nitric acid and nitrous acid or metal nitrite.
Adequate results using Solcoderm™ are achieved only if the recommended storage temperature and the use-by dates indicated are observed as accurately as possible, since fluctuations in the nitrite concentration due to storage temperature, storage time or prolonged exposure to oxygen may severely decrease the effectiveness of Solcoderm™.
In addition, it has been observed that preparations such as Solcoderm™, when inactive, present an increased danger of side effects and may for example lead to ulcerations on healthy skin.
Furthermore, due to the use of nitric acid, which is a strong oxidizing acid, Solcoderm™ treatment tends to destroy lesion tissue to an extent substantially negating the possibility of accurate post treatment histopathological study and diagnosis.
U.S. Pat. No. 5,573,786 describes an improved composition of Solcoderm™ which overcomes the stability limitations described above. This composition includes nitric acid and nitrite reduction products formed by reacting aqueous nitric acid with a primary C1–C5 alkanol. The primary alkanol is converted to C1–C5 alkanoic acid and carbon dioxide with the simultaneous formation of nitrate reduction products.
As stated in U.S. Pat. No. 5,573,786 this improved composition is useful for the treatment of common and plantar warts, pedal mycosis and onychomycosis.
Topical treatment methods using Solcoderm™ or its derivatives are oftentimes preferred over laser therapy or cryotherapy, since such treatment methods cause less of a discomfort to the treated individual and are easier and less expensive to conduct. However, the currently available composition is indicated for the treatment of warts and condylomata only.
Although a study performed by Cesarini from the Department of Dermatology, Foundation Rothschild, Paris, France (Dermatologica 168; suppl. 1. pp. 15–25 (1984)) suggested that the fixative properties of Solcoderm™ are adequate for histopathological diagnosis of post-treatment scabs, the same study demonstrated that when H & E staining is used (the single histochemical staining method used), the cellular elements stain in pale pink while the extra cellular compartment does not stain at all; furthermore, anisocytosis, anisokariosis and polychromatophilia, the usual landmarks of cytologists, cannot be observed and described.
There is thus a widely recognized need for, and it would be highly advantageous to have, compositions and methods of using same for effectively treating skin or mucous membrane lesions while enabling post treatment histopathological analysis of treated tissue.